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TerminatedNCT03324711MMENSEAUpdated Mar 9, 2022

Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination (MMSEa)

An interventional study of "Antillanisée" Mini Mental State Examination (MMSEa) in Elderly Patients, Cognitive Disorder and Alzheimer Disease, sponsored by University Hospital Center of Martinique. Terminated at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by University Hospital Center of Martinique · Not applicable, Interventional, and Other

Why this study was terminated
Departure of the Principal Investigator
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study summary

The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).

The methodology used will permit to explore the feasibility, acceptability, validity and reliability of the tool.

The psychometric validation of a version adapted transculturally will increase the value of the results obtained with this test and will make it possible to refine the screening of existing cognitive disorders for elderly subjects with Alzheiner's disease or related disorders.

Read the detailed description

Patients will be recruited at the Geriatric Day Hospital.

These patients came to a geriatric day hospital for examination without restriction on the reason for the hospitalization.

They are referred by their general practitionner or referred by a specialist physician, live at home or in an institution and are representative of the geriatric population addressed by the MMSEa.

  • The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).
  • The ancillary objective of this study will be to carry out the psychometric validation of the Short Physical Performance Battery (SPPB) in people aged 65 years or older.

It is an instrument for measuring the physical performance of subjects whose transcultural adaptation and psychometric validation have already been performed in subjects aged 65 to 74 years.

SPPB is used routinely in our routine practice in a day hospital, with no psychometric validation performed on this population. This ancillary objective will not modify the course of the MMSEa validation study since the SPPB is part of the evaluation tools.

02

Conditions studied

  • Elderly Patients
  • Cognitive Disorder
  • Alzheimer Disease

Keywords

  • Cognitive disorders
  • Alzheimer's disease
  • Mini Mental State Examination
  • Geriatry
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject of 65 years old and over
  • Subject admitted in a geriatric day hospital
  • Patients of creole culture
  • Subject having French and/or Creole as mother tongue
  • Subject able to undergo neuropsychological tests
  • Subject having given informed consent or, informed consent given by his or her primary caregiver
  • Subject affiliated to a social security scheme

Exclusion criteria

Exclusion Criteria:

  • Subject with a disability seriously compromising oral communication (understanding and expression)
  • Subject with behavioral disorder that does not allow for testing
  • Subject in general condition not allowing its participation in the tests
  • Subject involved in another study including an exclusion period still in progress at the time of inclusion
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Other
    Elderly patient (65 and more)

    Ederly patients seen in geriatric day hospital, from creole culture.

    Diagnostic Test: "Antillanisée" Mini Mental State Examination (MMSEa)

Interventions

  • Diagnostic test"Antillanisée" Mini Mental State Examination (MMSEa)

    "Antillanisée" version of the Mini Mental State Examination (MMSEa), is a version adaptated to the French West Indies creole culture.

    Also known as: MMSEa

05

What researchers measure

Primary outcomes

  1. Evaluation of the psychometric properties of the questionnaire MMSEa

    The following will be measured: * feasibility and acceptability; * validity of structure; * discriminant validity; * predictive validity; * validity of convergence; * reliability (internal consistency,reproducibility (test-retest)).

    Time frame: 12 month (+/- 15 days)

Secondary outcomes

  1. Evaluation of the psychometric properties of questionnaire SPPB

    The following will be measured: * feasibility and acceptability; * validity of structure; * discriminant validity; * predictive validity; * reliability (internal consistency,reproducibility (test-retest)).

    Time frame: 12 month (+/- 15 days)

06

Study locations

1 site
  • CHU de Martinique
    Fort-de-France, Martinique 97200, France
07

Registry details

Key details

Study ID
NCT03324711
Lead sponsor
University Hospital Center of Martinique
Responsible party
Sponsor
First posted
Oct 30, 2017
Start date
Nov 15, 2016
Primary completion
Apr 11, 2019
Completion
Jul 2019
Last update
Mar 9, 2022

Study contacts

Lidvine GODAERT-SIMON, MD
principal investigator · CHU of Martinique

Oversight

Data monitoring committee
No
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